elagolix versus subcutaneous depot medroxyprogesterone acetate for the treatment of endometriosis

Conditions: Endometriosis

Summary: this study is designed to assess the effects of elagolix versus subcutaneous depot medroxyprogesterone acetate (dmpa-sc; also known as depo-provera) on bone mineral density (bmd) during treatment for 24 weeks with a subsequent 24-week post-treatment period.


Eligibility criteria:
inclusion criteria: * be female, aged 18 to 49 years, inclusive * have a total cpsss of ≥ 6 at screening and baseline (day 1) in the following categories: dysmenorrhea, dyspareunia, nonmenstrual pelvic pain, pelvic tenderness and induration. the total score must include a total of at least 2 in each of the categories of dysmenorrhea and nonmenstrual pelvic pain. * have had a diagnosis of endometriosis made following laparoscopic visualization of the disease within 8 years of the start of screening with recurrent or persistent symptoms. * have documented negative mammogram results within 12 months of screening if over the age of 40 years. * have menstrual cycles (28 days ±5 days). assessment of cycle duration should be based on observations in the absence of drugs or conditions that are known to affect the cycle (e.g., oral contraceptives, leuprolide, pregnancy). * have a body mass index (bmi) between 18 and 36 kg/m², inclusive. * agree to use two forms of nonhormonal contraception (e.g. condom with spermicide) during the study. exclusion criteria: * are currently receiving gonadotropin-releasing hormone (gnrh) agonist, gnrh antagonist, danazol, or have received any of these agents within 6 months of the start of screening. * are currently receiving subcutaneous medroxyprogesterone acetate (dmpa-sc) or intramuscular medroxyprogesterone acetate (dmpa-im) or have received any of these agents within 3 months of the start of screening. * have been nonresponsive to gnrh agonist or antagonist therapy for the management of endometriosis. * are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within 1 month of the start of screening. * have had surgical treatment for endometriosis (laparoscopy) within 1 month of the start of screening. * have had a hysterectomy or bilateral oophorectomy. * have had prior treatment with nbi-56418. * have uterine fibroids or other pelvic lesions ≥ 5 cm in diameter * have any of the following abnormal cervical smear results at screening (based on the 2001 bethesda system): * benign endometrial cells (bec) present, provided subject has irregular uterine bleeding or is over 40 years old * atypical squamous cells of undetermined significance (asc-us) present, and human papilloma virus (hpv) reflex testing is positive for high risk types or the testing outcome is unknown * atypical squamous cells present, and high-grade squamous intraepithelial lesion (asc-h) cannot be excluded * atypical glandular cells of uncertain significance (agus/agc): not otherwise specified (nos), favor neoplasia (fn), favor endocervical, or favor endometrial origin types * low-grade squamous intraepithelial lesion (lsil) present * high-grade squamous intraepithelial lesion (hsil) present * adenocarcinoma in situ (ais) / malignant cells present * have bmd with either lumbar spine or femur t-scores below -1.5 at screening as determined by the central dxa facility or have history of pathologic or compression fractures. * have been pregnant within 6 months of screening or currently breast feeding * are using systemic steroids on a chronic or regular basis within 3 months * have unstable medical condition or chronic disease * have chronic pelvic pain that is not caused by endometriosis